SANITIZATION TECHNIQUES FOR WATER SYSTEM IN PHARMA
SANITIZATION:- Microbial control in water systems is achieved primarily through sanitization practices. Systems can be sanitized using either thermal or (photo-) chemical means.
THERMAL SANITIZATION:- Thermal approaches to system sanitization include periodic or continuously circulating hot water and the use of steam. Temperatures of 65°–80° are most commonly used for thermal sanitization. Continuously recirculating water of at least 65° at the coldest location in the distribution system has also been used effectively in stainless steel distribution systems when attention is paid to uniformity and distribution of such self-sanitizing temperatures. These techniques are limited to systems that are compatible with the higher temperatures needed to achieve sanitization. Frequent use of thermal sanitization at appropriate temperatures should eliminate the need for other sanitization methods.
The use of thermal methods at temperatures above 80° is contraindicated because it does not add to microbial control of the system or reduction of biofilm. Some methods (e.g., steam sanitizing, hot water circulation at temperatures 100°) can be less effective or even destructive because of the need to eliminate condensate or manipulate system components, stress materials of construction, deform filters, and its adverse impact on instrumentation.
Although thermal methods control biofilm development by either continuously inhibiting its growth or, in intermittent applications, by killing the microorganisms within developing biofilms, they are not effective in removing established biofilms.
Killed but intact biofilms can become a nutrient source for rapid biofilm regrowth after the sanitizing conditions are removed or halted. In cases of infrequent thermal sanitizations that allow biofilm development between treatments, a combination of routine thermal treatment and periodic supplementation with chemical sanitization may be more effective. The more frequent the thermal sanitization, the more likely it is that biofilm re-development can be eliminated.
CHEMICAL SANITIZATION:- Chemical methods, where compatible, can be used on a wider variety of construction materials. These methods typically use oxidizing agents such as ozone, hydrogen peroxide, peracetic acid, or combinations thereof. Halogenated compounds can be effective sanitizers but are less aggressive oxidizing agents and may be difficult to flush from the system.
Chemical agents may not penetrate the full biofilm matrix or extend into all biofilm locations (such as crevices at gasketed fittings) and may leave biofilms incompletely inactivated. Compounds such as ozone, hydrogen peroxide, and peracetic acid oxidize bacteria and biofilms with reactive peroxides and by forming very reactive free radicals (notably hydroxyl radicals). The short half-life of ozone in particular, and its limitation on achievable concentrations, requires that it be added continuously during the sanitization process.
Hydrogen peroxide and ozone rapidly degrade to water and/or oxygen, and peracetic acid degrades to oxygen and acetic acid. The ease of degradation of ozone to oxygen using 254-nm UV lights in circulating loops allows it to be used effectively on a continuously sanitizing basis in holding tanks and on an intermittent basis (e.g., daily or weekly) in the distribution loops. The highly reactive nature of ozone requires the use of system materials and components that are even more oxidation resistant than those typically used with the other oxidizing agents.
It is important to note that microorganisms in a well-developed biofilm can be extremely difficult to kill, even by using aggressive oxidizing chemicals. The less developed and therefore thinner the biofilm, the more effective the biofilm inactivation.
Therefore, optimal microbial control is achieved by using oxidizing chemicals at a frequency that does not permit significant biofilm development between treatments.
Validation of chemical sanitization requires demonstration of adequate chemical concentrations throughout the system, exposure to all wetted surfaces including the body of use point valves, and complete removal of the sanitant from the system at the completion of treatment. Methods validation for the detection and quantification of residues of the sanitant or its objectionable degradants is an essential part of the validation program.
UV SANITIZATION:- In-line UV light at a wavelength of 254 nm can also be used to continuously “sanitize” only the water circulating in the system, but these devices must be properly sized for the water flow. Such devices inactivate a high percentage (but not 100%) of microorganisms that flow through the device but cannot be used to directly control existing biofilm upstream or downstream of the device. However, when coupled with conventional thermal or chemical sanitization technologies or located immediately upstream of a microbially retentive filter, UV light is most effective and can prolong the interval between needed system resanitizations.
SANITIZATION PROCEDURES:- Sanitization steps require validation to demonstrate the ability to reduce and hold microbial contamination at acceptable levels.
Validation of thermal methods should include a heat distribution study to demonstrate that sanitization temperatures are achieved throughout the system, including the body of use point valves; sampling ports; instrument side branches; and fittings, couplings, and adapters, relying on water convection and thermal conduction through system materials for heat transfer to wetted surfaces.
The routine frequency of sanitization should be supported by the results of system microbial monitoring.
Conclusions derived from trend analysis of the microbiological data should be used as the alert mechanism for the need for extraordinary maintenance.
The routine frequency of sanitization should be established in such a way that the system operates in a state of microbiological control and does not regularly exceed Alert and Action Levels.
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